Clinical Study to Assess the Immunomodulatory and Antioxidant Effects of a Beverage Manufactured From Lupine Protein Hydrolysates in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Assessment of the change from baseline of the plasma gluthathione reductase activity
研究概览
简要总结
The purpose of this study is to determine the health effects of the 4 weeks daily intake of a drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism, together with general hematology and blood coagulation will be assessed at baseline time (day 0) and after drink ingestion (day +14 and +28).
详细描述
The main objective of the present study is to verify the hypothesis that the intake of the drink based on lupine peptides is safe and has beneficial effects on the immune and oxidative status.
The secondary objectives are:
- Assess the effect of the drink on biological parameters of the carbohydrate, lipid, renal and hepatic metabolism as well as hematology analysis.
- Assess whether the new product is well tolerated.
- Evaluate the effect of the drink on the general health of the volunteers through the Short Form-36 health survey.
- Determine the degree of drink acceptability through the acceptability Likert test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject between 18 and 50 years old
- •Body mass index between 19 and 26 kg/m2
- •No severe disease
- •Biochemical markers within the normal range
- •No previous history of drug abuse
- •Negative serology for hepatitis C virus (HCV), hepatitis B virus (HBV) and HIV
- •Females must have a negative pregnancy test
- •The volunteer should signed the informed consent approved by the Ethics Committees of Clinical Trials
排除标准
- •Pre-existing disease
- •Treatment with anti-inflammatory, antipyretic or antibiotic drugs
- •Harmful alcohol consumption according to World Health Organization standards
- •Pregnant females
- •Hypersensitivity to lupine, corn or xanthan gum.
- •Allergies to plant derivatives and celiac.
- •Participation in another clinical trial.
- •Blood donation in the previous three months.
- •Any other circumstance that according to the research team may lead to increased risk for voluntary
结局指标
主要结局
Assessment of the change from baseline of the plasma gluthathione reductase activity
时间窗: day 0 (baseline), +14, +28, +42
Plasma gluthathione reductase activity
Assessment of the change from baseline of the plasma total antioxidant activity
时间窗: day 0 (baseline), +14, +28, +42
Plasma total antioxidant activity
Assessment of the change from baseline of the plasma superoxide dismutase activity
时间窗: day 0 (baseline), +14, +28, +42
Plasma superoxide dismutase activity
Assessment of the change from baseline of the plasma catalase activity
时间窗: day 0 (baseline), +14, +28, +42
Plasma catalase activity
Assessment of the change from baseline of the plasma gluthathione peroxidase activity
时间窗: day 0 (baseline), +14, +28, +42
Plasma gluthathione peroxidase activity
Assessment of the change from baseline of the plasma levels of immunoglobulins
时间窗: day 0 (baseline), +14, +28, +42
plasma levels of immunoglobulin A, immunoglobulin E, immunoglobulin G and immunoglobulin M
Assessment of the change from baseline of the plasma levels of complement
时间窗: day 0 (baseline), +14, +28, +42
plasma levels of C3 and C4
Assessment of the change from baseline of the plasma levels of C reactive protein
时间窗: day 0 (baseline), +14, +28, +42
Plasma levels of C reactive protein
Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells
时间窗: day 0 (baseline), +14, +28, +42
Supernatant levels of Interleukin (IL-1)beta, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-17, IL-22, IFNgamma and Tumour necrosis factor (TNF)-alpha
次要结局
- Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT)(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of homocysteine(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of total proteins(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of cholesterol(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of urea(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of alkaline phosphatase(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST)(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of haematological markers(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of insulin(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of creatinine(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of glucose(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of triglycerides(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT)(day 0 (baseline), +14, +28, +42)
- Assessment of the change from baseline of the Body Mass Index(day 0 (baseline), +14, +28, +42)
研究者
Antonio Carrillo Vico
PhD
University of Seville